We use cookies to improve your experience. By continuing to browse this site, you accept our cookie policy.×
Skip main navigation
Open Drawer MenuClose Drawer Menu
Aging Health
Bioelectronics in Medicine
Biomarkers in Medicine
Breast Cancer Management
CNS Oncology
Colorectal Cancer
Concussion
Epigenomics
Future Cardiology
Future Medicine AI
Future Microbiology
Future Neurology
Future Oncology
Future Rare Diseases
Future Virology
Hepatic Oncology
HIV Therapy
Immunotherapy
International Journal of Endocrine Oncology
International Journal of Hematologic Oncology
Journal of 3D Printing in Medicine
Lung Cancer Management
Melanoma Management
Nanomedicine
Neurodegenerative Disease Management
Pain Management
Pediatric Health
Personalized Medicine
Pharmacogenomics
Regenerative Medicine
Device Evaluation

Maturation from CoreValve® to Evolut Pro®: a clinical overview

    Maarten P van Wiechen

    Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, 3015 GD Rotterdam, The Netherlands

    Search for more papers by this author

    &
    Nicolas M Van Mieghem

    *Author for correspondence: Tel.: +31 010 703 5260;

    E-mail Address: n.vanmieghem@erasmusmc.nl

    Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, 3015 GD Rotterdam, The Netherlands

    Search for more papers by this author

    Published Online:19 Dec 2018https://doi.org/10.2217/fca-2018-0064

    Abstract

    The only curative treatment of aortic stenosis is through surgical or transcatheter aortic valve replacement. Transcatheter aortic valve implantation has evolved from its first in human experience in 2002 and matured to the treatment of first choice of symptomatic severe aortic stenosis in elderly patients with an elevated operative risk. The self-expanding CoreValve® bioprosthesis has been on the forefront of this growing transcatheter aortic valve implantation experience. Over the last decade, various device iterations resulted in the current Evolut PRO® self-expanding valve platform with reduced profile, repositioning/retrievable features and porcine pericardial wrap. Herein we provide a critical appraisal of the consecutive device iterations and highlight the clinical foundation for the use of the self-expanding CoreValve® /Evolut platforms in current clinical practice.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

    References

    • 1 Iung B, Baron G, Butchart EG et al. A prospective survey of patients with valvular heart disease in Europe: the Euro heart survey on valvular heart disease. Eur. Heart J. 24(13), 1231–1243 (2003).
      MedlineGoogle Scholar
    • 2 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet 368(9540), 1005–1011 (2006).
      MedlineGoogle Scholar
    • 3 Turina J, Hess O, Sepulcri F, Krayenbuehl HP. Spontaneous course of aortic valve disease. Eur. Heart J. 8(5), 471–483 (1987).
      Medline CASGoogle Scholar
    • 4 Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur. Heart J. 38(36), 2739–2791 (2017).
      MedlineGoogle Scholar
    • 5 Nishimura RA, Otto CM, Bonow RO et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. J. Am. Coll. Cardiol. 70(2), 252–289 (2017).
      MedlineGoogle Scholar
    • 6 Leon MB, Smith CR, Mack MJ et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N. Engl. J. Med. 374(17), 1609–1620 (2016). •• Comparison between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement using a balloon-expandable prosthesis in patients at intermediate risk for surgery. TAVI was noninferior to surgery in terms of stroke and mortality.
      Medline CASGoogle Scholar
    • 7 Reardon MJ, Van Mieghem NM, Popma JJ et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N. Engl. J. Med. 376(14), 1321–1331 (2017). •• Comparison between TAVI and surgical aortic valve replacement using a self-expanding prosthesis in patients at intermediate risk for surgery. TAVI was noninferior to surgery in terms of stroke and mortality.
      MedlineGoogle Scholar
    • 8 Spitzer E, Van Mieghem NM, Pibarot P et al. Rationale and design of the transcatheter aortic valve replacement to UNload the left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial. Am. Heart J. 182, 80–88 (2016).
      MedlineGoogle Scholar
    • 9 Cahill TJ, Chen M, Hayashida K et al. Transcatheter aortic valve implantation: current status and future perspectives. Eur. Heart J. 39(28), 2625–2634 (2018).
      Medline CASGoogle Scholar
    • 10 Chamandi C, Puri R, Rodriguez-Gabella T, Rodes-Cabau J. Latest-generation transcatheter aortic valve replacement devices and procedures. Can. J. Cardiol. 33(9), 1082–1090 (2017).
      MedlineGoogle Scholar
    • 11 Van Gils L, Tchetche D, Latib A et al. TAVI with current CE-marked devices: strategies for optimal sizing and valve delivery. EuroIntervention 12(Y), Y22–Y27 (2016).
      MedlineGoogle Scholar
    • 12 Cribier A, Eltchaninoff H, Bash A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24), 3006–3008 (2002). • First-in-human TAVI.
      MedlineGoogle Scholar
    • 13 Grube E, Laborde JC, Zickmann B et al. First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis. Catheter. Cardiovasc. Interv. 66(4), 465–469 (2005). • First-in-human TAVI using a self-expanding device.
      MedlineGoogle Scholar
    • 14 Carroll JD, Vemulapalli S, Dai D et al. Procedural experience for transcatheter aortic valve replacement and relation to outcomes: the STS/ACC TVT registry. J. Am. Coll. Cardiol. 70(1), 29–41 (2017).
      MedlineGoogle Scholar
    • 15 Di Mario C, Eltchaninoff H, Moat N et al. The 2011–12 pilot European sentinel registry of transcatheter aortic valve implantation: in-hospital results in 4571 patients. EuroIntervention 8(12), 1362–1371 (2013).
      MedlineGoogle Scholar
    • 16 Grube E, Laborde JC, Gerckens U et al. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 114(15), 1616–1624 (2006).
      MedlineGoogle Scholar
    • 17 Piazza N, Martucci G, Lachapelle K et al. First-in-human experience with the Medtronic CoreValve Evolut R. EuroIntervention 9(11), 1260–1263 (2014).
      MedlineGoogle Scholar
    • 18 Forrest JK, Mangi AA, Popma JJ et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. JACC Cardiovasc. Interv. 11(2), 160–168 (2018). • Clinical data on the newest generation self-expanding valve.
      MedlineGoogle Scholar
    • 19 Leon MB, Smith CR, Mack M et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N. Engl. J. Med. 363(17), 1597–1607 (2010). •• In inoperable patients with severe aortic stenosis, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause.
      Medline CASGoogle Scholar
    • 20 Popma JJ, Adams DH, Reardon MJ et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J. Am. Coll. Cardiol. 63(19), 1972–1981 (2014). •• TAVI with a self-expanding bioprosthesis is safe and effective in patients with severe aortic stenosis at a prohibitive risk for surgical valve replacement.
      MedlineGoogle Scholar
    • 21 Adams DH, Popma JJ, Reardon MJ et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N. Engl. J. Med. 370(19), 1790–1798 (2014). •• In patients with an increased surgical risk, the rate of death from any cause at 1 year was significantly lower in TAVI with a self-expanding valve than in the surgical group.
      Medline CASGoogle Scholar
    • 22 Arnold SV, Reynolds MR, Wang K et al. Health status after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis at increased surgical risk: results from the CoreValve US Pivotal Trial. JACC Cardiovasc. Interv. 8(9), 1207–1217 (2015).
      MedlineGoogle Scholar
    • 23 Thyregod HG, Steinbruchel DA, Ihlemann N et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1 year results from the all-comers NOTION randomized clinical trial. J. Am. Coll. Cardiol. 65(20), 2184–2194 (2015).
      MedlineGoogle Scholar
    • 24 Abdel-Wahab M, Mehilli J, Frerker C et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 311(15), 1503–1514 (2014).
      Medline CASGoogle Scholar
    • 25 Abdel-Wahab M, Neumann FJ, Mehilli J et al. 1-year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves: results from the CHOICE randomized clinical trial. J. Am. Coll. Cardiol. 66(7), 791–800 (2015).
      MedlineGoogle Scholar
    • 26 Feldman TE, Reardon MJ, Rajagopal V et al. Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: the REPRISE III randomized clinical trial. JAMA 319(1), 27–37 (2018).
      MedlineGoogle Scholar
    • 27 Linke A, Wenaweser P, Gerckens U et al. Treatment of aortic stenosis with a self-expanding transcatheter valve: the international multi-centre ADVANCE study. Eur. Heart J. 35(38), 2672–2684 (2014).
      MedlineGoogle Scholar
    • 28 Gerckens U, Tamburino C, Bleiziffer S et al. Final 5 year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE study. Eur. Heart J. 38(36), 2729–2738 (2017).
      MedlineGoogle Scholar
    • 29 Grube E, Van Mieghem NM, Bleiziffer S et al. Clinical outcomes with a repositionable self-expanding transcatheter aortic valve prosthesis: the international FORWARD study. J. Am. Coll. Cardiol. 70(7), 845–853 (2017).
      MedlineGoogle Scholar